510(k) · Cleared
ClearedConsolidated Operating Room Equipment (CORE) 2 Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · OLO Orthopedic Stereotaxic Instrument
Cleared on Mar 21, 2025 as substantially equivalent to K241171 (Stryker Leibinger GmbH & Co KG, 2024) after an 88-day review. Its family tree reaches back 17 generations to 1985. 1 of the 78 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 21, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K853033 (1985). 77 ancestors in all. No later device cites it as a predicate yet. 1 of the 78 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations between
- 3 generations backK203205 Navigated Spine InstrumentsStryker Spine · 2021
- 2 generations backK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- 1 generation backK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- This deviceK243958 Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments · 2025
Show all 17 generations
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 8 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 7 generations backK062327 Modification to S4 Spinal SystemAesculap, Inc. · 2007
- 6 generations backK130887 S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013
- 5 generations backK181890 Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
- 4 generations backK192911 Brainlab Compatible K2M Navigation InstrumentsK2m, Inc. · 2019
- 3 generations backK203205 Navigated Spine InstrumentsStryker Spine · 2021
- 2 generations backK240662 Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments…Stryker Leibinger GmbH & Co KG · 2024
- 1 generation backK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- This deviceK243958 Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments · 2025
Class I recalls in this family
- K070106 VV Fluoro 3D7 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −16 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −15 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −14 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −13 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −12 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −11 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −10 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −8 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| −7 | K062327 | Modification to S4 Spinal System | Aesculap, Inc. | 2007 | — |
| −6 | K130887 | S4C Navigation Instruments | Aesculap Implant System, Inc. | 2013 | — |
| −5 | K181890 | Brainlab Compatible K2M Navigation Instruments | K2m | 2018 | — |
| −4 | K192911 | Brainlab Compatible K2M Navigation Instruments | K2m, Inc. | 2019 | — |
| −3 | K203205 | Navigated Spine Instruments | Stryker Spine | 2021 | — |
| −2 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| −1 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| 0 (this device) | K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Instruments | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Summary page 5…(21 CFR 882.4560) Product Code(s): OLO (Secondary ERL, HWE, HBE) 807.92(a)(3) – Legally marketed device to which equivalence is claimed CORE 2 Console (K241171) 807.92(a)(4) – Device Description The CORE 2 Console is a non-sterile, 120V AC-powered, reusable device that is intended for use… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 7 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 12 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 77 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K241171.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243958: Consolidated Operating Room Equipment (CORE) 2 Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243958
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026